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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Therapeutic Response, Decreased (2271)
Event Date 09/14/2017
Event Type  Injury  
Manufacturer Narrative
Adeeb, n. , moore, j. , wirtz, m. , griessenauer, c. , foreman, p. , shallwani, h. ,. Ogilvy, c. (2017). Predictors of incomplete occ lusion following pipeline embolization of intracranial aneurysms: is it less effective in older patients? american journal of neuroradiology, 38(12), 2295-2300. Doi:10. 3174/ajnr. A5375 the pipeline devices will not be returned for evaluation as they remain implanted in the patients. Based on the provided information, there does not appear to have been any defect of the devices during use. The events occurred in the patients post-procedure and the causes could not be conclusively determined from the provided information. Mdrs related to this article: 2029214-2018-00336 2029214-2018-00337. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic literature review found reports of patient complications after pipeline implantation. The purpose of this article was to assess predictors of incomplete occlusion after pipeline embolization device (ped) treatment. The authors retrospectively reviewed 380 aneurysms treated by 329 ped procedures in 329 patients. Of the 329 patients, 272 were female and 57 were male; the median age was 58 years. The article noted the following outcomes after ped placement: - 24 patients underwent endovascular retreatment - 31 patients experienced thromboembolic complications, 17 of which were symptomatic - 11 patients experienced hemorrhagic complications, 6 of which were symptomatic.
 
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Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key7452653
MDR Text Key106244611
Report Number2029214-2018-00336
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/23/2018 Patient Sequence Number: 1
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